BEUDAMED
    FDA Adverse Event Summary report: N

    FORCEPS MCL19 LEFT BOUCHAYER HEART [MXI/XOM]

    MDR report key: 2831577 · Received November 14, 2012

    Report

    Report Number
    9680837-2012-00025
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS: THE DEVICE WAS RECEIVED BY THE QUALITY ENGINEER FOR INSTRUMENTS. EXAMINATION FOUND THE LOWER JAW WAS OBSERVED TO BE BROKEN AT THE BOTTOM. A CLOSE LOOK ON THE FRACTURE AREA HAS NOT HIGHLIGHTED ANY MATERIAL DEFECT OR CORRODED AREA. IT WAS NOTED THAT THE INSTRUMENT IS SLIGHTLY OVER BENT COMPARED TO THE FACTORY REFERENCE AND SOME TRACES OF IMPACTS HAVE BEEN OBSERVED ON THE REMAINING PART OF THE BROKEN JAW. THE ABSENCE OF CORRODED ZONE OR MATERIAL DEFECT ON THE BREAKAGE ZONE INDICATES THAT THE FRACTURE HAS BEEN SUDDEN. WE CAN REASONABLY SUSPECT THAT THE BREAKAGE OR THE PRECEDING DAMAGE IS DUE TO AN EXCESSIVE TIGHTENING OR AN ATTEMPT OF TIGHTENING A HARD OR TOO THICK SURFACE OR DURING THE REPROCESSING OF THE INSTRUMENT. THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. DEVICE DESCRIPTION: AN EAR, NOSE, AND THROAT MANUAL SURGICAL INSTRUMENT IS ONE OF A VARIETY OF DEVICES INTENDED FOR USE IN SURGICAL PROCEDURES TO EXAMINE OR TREAT THE BRONCHUS, ESOPHAGUS, TRACHEA, LARYNX, PHARYNX, NASAL AND PARANASAL SINUS, OR EAR. IT IS THE RESPONSIBILITY OF THE SURGICAL TEAM TO SELECT THE APPROPRIATE INSTRUMENT FOR EACH CASE CHECK THE CONDITION OF INSTRUMENTS BEFORE AND AFTER EACH CASE. REMOVE FROM USE ANY INCOMPLETE OR POORLY OPERATING INSTRUMENTS. DO NOT BEND, PRY, OR USE EXCESSIVE FORCE, BREAKAGE OR FAILURE OF THE INSTRUMENT COULD OCCUR RESULTING IN POSSIBLE HARM TO THE PATIENT OR USER. INSPECT COMPONENTS FOR ANY DAMAGE BEFORE AND AFTER EACH USE. IF DAMAGE IS OBSERVED DO NOT USE THE INSTRUMENT UNTIL IT IS REPAIRED. AFTER CLEANING AND STERILIZATION, VERIFY FUNCTIONALITY PRIOR TO RE-USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A LARYNGOSCOPY, THE EXTREMITY [LOWER JAW] OF THE PLIERS HAS SUDDENLY BROKEN. THE FRAGMENT COULD NOT BEEN RETRIEVED DESPITE THE SEARCH; A RADIOLOGY CHECK HAS BEEN ASKED. NO IMMEDIATE PATIENT IMPACT AFTER SURGERY. A POST-OPERATIVE CLINICAL SURVEILLANCE AND RADIOLOGY CHECK HAVE BEEN CARRIED OUT. THE FRAGMENT HAS NOT BEEN DETECTED DURING THE RADIOLOGY. THE SURGEON SUPPOSES THAT IT HAS BEEN SUCKED DURING THE SURGERY. THE PATIENT HAS LEFT THE HOSPITAL WITHOUT CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCEPS MCL19 LEFT BOUCHAYER HEART [MXI/XOM] INSTRUMENT, ENT MANUAL SURGICAL LRC XOMED MICROFRANCE MFG MCL19 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention